QGE

Biliary Stent, Drain, And Dilator Accessories

Product code

QGE

Device name

Biliary Stent, Drain, And Dilator Accessories

Device class

Class 1

21 CFR

21 CFR 876.5012

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

FDA classification definition

Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.

Definition text from the FDA device classification database (U.S. federal government work, public domain).